Berlin Heals Unveils Promising Findings from CMIC-III Study

Berlin Heals Holding AG has announced positive outcomes from its CMIC-III First-In-Human study, presented at the Heart Rhythm Society's Congress in Chicago. The study showcases a less invasive approach for implanting the cardiac microcurrent (CMIC) device, indicating significant improvements in left ventricular ejection fraction, 6-minute walk test, quality of life, and New York Heart Association class.

This outpatient procedure marks the first time the CMIC system is implanted without surgery, aligning with previous pericardial surgical results while enhancing safety. These advancements suggest broader access for heart failure patients.

The Phase II expansion targets patients with mildly reduced ejection fractions, while a concurrent C-MIC-IV trial aims to include patients with both ischemic and non-ischemic heart failure. Berlin Heals plans to increase the patient base to 122, informing a pivotal FDA IDE trial.